Safety determines the highest possible dose level which can deliver the desired clinical benefit and takes into account any potential adverse side effects.

Effectiveness describes a drugs ability to be used under real-world conditions such as in cases of co-morbidity, interacting drugs, or conditions which may not be as strictly controlled as a laboratory.

13

Describe the 5 phases of clinical trials.

Phase 0: First-in-man low-dose trials of between 10 and 15 individuals to test that the drug is effective towards the targets, though it is not expected to show clinical benefit or adverse effects. This phase may be conducted while waiting for IND review with prior approval.

Phase IV: Trials done after approval by the FDA. Number of subjects depends on previous trial endpoints. Doses vary. May be used to determine alternate uses for the drug. Further confirms clinical efficacy.

14

What is an MSR activator and which illness is it used to treat?

An Msr activator is used to reduce oxidative damage due to age by attacking methionine sulfate reductase.

15

Sancillo & Co. is known for research into what chemical?

Omega fatty acid for the treatment of such diseases as sickle cell and short-bowel syndrome.

16

Define API

Active pharmaceutical ingredient

17

Define GMP

Good manufacturing practices (all aspects of companies including labs)

18

Define cGMP

Current good manufacturing practices (current practicing requirements beyond those listed in GMP)

19

Define GLP

Good laboratory practices (primarily focuses on testing of animals).

20

Define GCP

Good clinical practices

21

Define QA

Quality Assurance (system which ensures that the drug product is made to the same standards each and every time it is made)

22

Define QC

Quality Control (mostly refers to the laboratory level of quality)

23

Define CFR

Code of Federal Registry (Laws)

24

21 CFR 211 defines what?

GMPs for drugs

25

21 CFR 111 defines what?

GMPs for supplements

26

21 CFR 110 defines what?

GMPs for human food

27

Define CRO

Contact research organization

28

Define CMO

Contract Manufacturing Organization

29

Define 3PL

3rd party logistics company

30

Define USP

United States Pharmacopeia (private company which sets the standards for drug manufacturing in the united states)

31

Define IP

Intellectual Property (Patents and trade secrets)

32

What is an FD483

A list of objectionable observations made during a regulatory investigation.

33

Define PAI

An FDA investigation of a pharma company or contractor prior to the approval of a drug or device.

34

Define BA/BE study

Bioavailability and bioequivalence clinical trial used by generic drug companies to gain approval.

35

Define CDER

Center for Drug Evaluation and Research of FDA

36

Define CBER

Center for Biologics Evaluation and Research of FDA

37

Define IND

Investigational new drug application

38

Define NDA

New drug application

39

Define NCE

New chemical entity

40

Define ANDA

Abbreviated new drug application (for generic companies)

41

Define SOP

Standard operating procedures

42

Define NF

National Formulary

43

What are the 5 drug schedules and give an example of each.

Schedule 1: High abuse rate with no known medical use. Cannabis and heroine.

What do in vitro tox studies intend to figure out?

Define bioassay.

A live system such as a culture, organ, or whole organism which can be used to measure drug effects.

49

What is Cmax?

The maximum serum concentration within a test subject.

50

What is Tmax?

The time at which Cmax is observed.

51

What is AUC?

Area under curve (reflective of total drug experience)

52

In acute toxicology studies, what does LD_50 stand for?

The dosage of drug required to kill 50 percent of test animals.

53

What is the goal of chronic toxicity studies?

Determination of the NOAEL (no observed adverse effect level), MTD (maximum tolerated dose), the MOS (margin of safety), and the shape of the dose-response curve.

54

What is MABEL?

Minimal anticipated biological effect levels

55

What is HED and how is it calculated? How is HED used to calculate ADI?

HED (human equivalent dose) is the NOAEL determined from animal toxicity studies converted to be acceptable for human intake. It is calculated by dividing the initial NOAEL by 10. The HED can be divided by 10 do give the ADI (acceptable daily intake).

56

Through which organization is animal treatment in laboratories managed?

IACUC (Institutional Animal Care and Use Committee)

57

What dictates the tests required for each dosage form?

The united states pharmacopeia.

58

Define specificity

The ability to identifiy analyte even in the presence of such expected components such as impurities and matrices.

59

What is precision?

The degree of agreement among all test results.

60

What is accuracy?

Closeness of test results to a "true" theoretical value.

61

What is range?

The upper and lower limit of analyte which has shown acceptable levels of precision, accuracy, and linearity.

62

Define robustness?

The measure of a procedure's capacity to remain unaffected by small deviations in the procedural parameters listed in the test method.

63

What is detection limit?

The lowest level of analyte able to be detected, but not necessarily quantified under the stated experimental conditions.

64

What is quantitation limit?

The lowest level of analyte which can be determined with the desired precision and accuracy under the stated experimental conditions.

65

What are the 4 categories of tests?

Category 1: Analytical procedure for a major component of the drug substance.